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510(k) Data Aggregation
K Number
K102189Device Name
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2012-03-14
(590 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows:
Cisplatin, 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml ≥ 240
Cytarabine, 100 mg/ml ≥ 240
Cytovene, 10 mg/ml ≥ 240
Dacarbazine (DTIC), 10.0 mg/ml ≥ 240
Docetaxel, 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride, 2.0 mg/ml ≥ 240
Etoposide (Toposar), 20.0 mg/ml ≥ 240
Fluorouracil, 50.0 mg/ml ≥ 240
Ifosfamide, 50.0 mg/ml ≥ 240
Irinotecan Hydrochloride, 20 mg/ml ≥ 240
Mechlorethamine HCI, 1.0 mg/ml ≥ 240
Methotrexate, 25 mg/ml ≥ 240
Mitomycin C, 0.5 mg/ml ≥ 240
Mitoxantrone, 2 mg/ml ≥ 240
Oxaliplatin, 5mg/ml ≥ 240
Paclitaxel (Taxol), 6.0 mg/ml ≥ 240
ThioTEPA 75.8
Vincristine Sulfate, 1.0 mg/ml ≥ 240
Vinorelbine, 10 mg/ml ≥ 240
Low Permeation Time (minutes) 1.7
Carmustine (BCNU), 3.3 mg/ml
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
Device Description
Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.
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K Number
K101645Device Name
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2010-08-26
(76 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Less Protein is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-051, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
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K Number
K034052Device Name
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2004-03-15
(76 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Black Colour Powder Free Nitrile Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Black Colour Powder Free Nitrile Rubber Examination Glove as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are black in colour and are powder free.
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K Number
K022346Device Name
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-10-18
(91 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Cleantexx <sup>TM</sup> Mint Flavour, Blue Colour Powder Free Barrier<br>Pro <sup>TM</sup> Polybutadiene Copolymer Examination Gloves<br>meets all the current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for Nitrile<br>Examination Gloves for Medical Application. They are<br>made from BarrierPro <sup>TM</sup> synthetic copolymer rubber latex, a<br>polybutadiene based copolymer. They are mint flavour,<br>blue in colour, are powder free.
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K Number
K022102Device Name
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-08-22
(55 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K022347Device Name
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-08-15
(27 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.
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K Number
K022548Device Name
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-08-15
(14 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.
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K Number
K022101Device Name
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-08-02
(35 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.
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K Number
K014087Device Name
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-03-04
(83 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove
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K Number
K013303Device Name
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
Manufacturer
LATEXX MANUFACTURING SDN.BHD.
Date Cleared
2002-01-23
(111 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX MANUFACTURING SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Synthetic Rubber Latex (BarrierPro™) Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
CleantexxTM Powder Free Synthetic Rubber Latex Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierProTM synthetic rubber latex, a polybutadiene based copolymer. They are natural white in color and are powder free.
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